EcoFit cup cementless implants with model numbers 02200046-02200068 may have loose plugs during bone impact, potentially requiring revision surgery. Affected units include specific sizes and lot numbers.
A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup, which could lead to operation duration extension or revision operation. A warning note is being added to instructions for use and surgical technique alerting users that the quality of bone in the patient (such as osteosclerosis) is an attributable factor.
IMPLANTCAST recalls certain EcoFit cup cementless hip implants due to a risk that plugs may become loose during bone impact, which could extend surgery time or require revision surgery. The hazard is linked to the patient's bone quality, such as osteosclerosis.
During hip replacement surgery, the acetabular cup is impacted into the bone. If the bone quality is osteosclerotic (dense), the plugs in the cup may become loose, potentially extending surgery time or requiring a revision operation.
Orthopedic surgeons and patients who have received the recalled EcoFit cup cementless implants (models 02200046-02200068) are most at risk. Patients with osteosclerotic bone are particularly vulnerable.
Check for model numbers 02200046 through 02200068 on the implant packaging or label. Lot numbers listed in the recall include specific sequences like 1736252001, 17420NM001, and others. The UDI (Unique Device Identifier) starts with 04048844005368 for the smallest model.
Identify the model number (02200046-02200068) and lot numbers listed in the recall to confirm if your implant is affected.
Reach out to IMPLANTCAST GMBH for further assistance or to confirm if your specific implant is part of the recall.
The recall occurs because the plugs in the EcoFit cup cementless implants may become loose during bone impact, especially in patients with osteosclerotic bone, which could lead to extended surgery or revision operations.
No, the recall does not require immediate discontinuation. However, if you have the affected models, you should contact IMPLANTCAST GMBH to confirm if your implant is part of the recall.
Check the model number and lot numbers against the list provided in the recall. If affected, contact IMPLANTCAST GMBH for further instructions.
We’ve drafted a message you can send IMPLANTCAST to request your refund or repair — edit it as you like.
Subject: Recall Z-2050-2021 — IMPLANTCAST IMPLANTCAST Hello, I own a IMPLANTCAST that is covered by recall Z-2050-2021 from IMPLANTCAST. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
